Trial Outcomes & Findings for VivaSight Double Lumen Tube for Single Lung Ventilation (NCT NCT03690284)
NCT ID: NCT03690284
Last Updated: 2022-01-14
Results Overview
The number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Intraoperative, within the time the double lumen was in the trachea
Results posted on
2022-01-14
Participant Flow
Participant milestones
| Measure |
Conventional Double Lumen Tube
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
|
VivaSight Double Lumen Tube
Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VivaSight Double Lumen Tube for Single Lung Ventilation
Baseline characteristics by cohort
| Measure |
Conventional Double Lumen Tube
n=25 Participants
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
|
VivaSight Double Lumen Tube
n=25 Participants
Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
57 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, within the time the double lumen was in the tracheaThe number of participants requiring flexible fiberoptic bronchoscopy during double-lumen tube intubation for a single lung ventilation.
Outcome measures
| Measure |
Conventional Double Lumen Tube
n=25 Participants
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
|
VivaSight Double Lumen Tube
n=25 Participants
Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
|
|---|---|---|
|
Number of Participants Requiring Flexible Fiberoptic Bronchoscopy
|
25 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Intraoperative, time to successfully intubate patient.The time required to place double lumen endotracheal tube for a single lung intubation
Outcome measures
| Measure |
Conventional Double Lumen Tube
n=25 Participants
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
|
VivaSight Double Lumen Tube
n=25 Participants
Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
|
|---|---|---|
|
The Intubation Time
|
156 seconds
Interval 103.0 to 174.0
|
54 seconds
Interval 45.0 to 81.0
|
SECONDARY outcome
Timeframe: Intraoperative, within the time the double lumen was in the tracheaThe number of participants with malposition of double lumen tube for a single lung intubation
Outcome measures
| Measure |
Conventional Double Lumen Tube
n=25 Participants
Patient will be intubated with conventional double lumen endotracheal tube for single lung ventilation during thoracic surgery.
Conventional Double Lumen Tube: Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
|
VivaSight Double Lumen Tube
n=25 Participants
Patient will be intubated with VivaSight double lumen endotracheal tube for single lung ventilation during thoracic surgery.
VivaSight Double Lumen Tube: Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
|
|---|---|---|
|
Number of Participants With Malposition
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: This outcome was not measured and no data was collected due to lack of resources to conduct the analysis.
Outcome measures
Outcome data not reported
Adverse Events
Conventional Double Lumen Tube
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VivaSight Double Lumen Tube
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Research Coordinator
University of Texas Southwestern
Phone: 3106127741
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place